Brain Blood Flow and Cerebral Autoregulation Monitoring in Critically Ill Children
Transcranial Doppler Assessment of Cerebral Autoregulation and Blood Flow Velocity Patterns in Critically Ill Children: A Prospective Observational Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 1 Day to 17 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Ultrasound
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "This study uses a non-invasive (external) ultrasound test called Transcranial Doppler (TCD) to measure how blood flows through the major arteries of the brain of children receiving care in the Pediatric Intensive Care Unit (PICU)."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study uses ultrasound outside the head to measure brain blood flow in very sick children in a pediatric intensive care unit (PICU). It looks at how blood flow changes during illness and how these changes relate to brain function and daily abilities. It is for children ages 1 day to 17.5 years who need a breathing machine.
This study uses a non-invasive (external) ultrasound test called Transcranial Doppler (TCD) to measure how blood flows through the major arteries of the brain of children receiving care in the Pediatric Intensive Care Unit (PICU). TCD is already used for clinical reasons in many children, but it is not part of routine monitoring for every critically ill child. By using TCD, the investigators hope to better understand how brain blood flow changes during illness. They will also track children's functional status from before their illness to the time of PICU discharge to explore how brain blood flow patterns relate to neurological outcomes.125 participants will be enrolled and will be on study while in the PICU, estimated to be 3-14 days.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- A parent or legal guardian is willing and able to give informed consent in English.
- Uses a breathing machine through a tube placed in the windpipe.
- Has a tube called a catheter in an artery.
- Is a patient in the American Family Children's Hospital PICU.
- Is 1 day to 17.5 years old.
Who can't join
- Has head bandages, hardware, devices, or skull changes that prevent safe use of the ultrasound probe.
- Has known long-term high blood pressure.
- Has a Functional Status Scale (FSS) score above 16 at admission. This score measures daily abilities and care needs.
- Has a tracheostomy, a breathing opening made through the neck into the windpipe.
- Neither of the two study doctors who perform the ultrasound scans is available when the child is eligible.
- The study doctors decide the child is not suited to take part for another reason.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Has at least one Parent or Legal Guardian who is willing and able to provide informed consent in English * Mechanically ventilated (Endotracheal tube) * Indwelling arterial catheter * Current patient in the American Family Children's Hospital PICU. * 1 day to 17.5 years of age Exclusion Criteria: * Subjects with a known or obvious anatomic barrier preventing safe application of the transcranial Doppler probe (e.g., cranial dressings, cranial fixation hardware, ventricular access devices positioned over insonation sites, or bilateral craniectomies) * Patient with known chronic hypertension * Admission FSS score \> 16 * Tracheostomized patient * The designated sub-investigator (Dr. Talal Al Hendawi) and PI (Dr. Neil Munjal) are unavailable to perform the Transcranial Doppler scan at the time of eligibility. All study scans are performed by either Dr. Al Hendawi or Dr.Munjal to ensure standardization and data integrity. Therefore, if they are unavailable (e.g., due to clinical service, leave, or other scheduling constraints), the patient will not be enrolled in the study. * Not suitable for study participation due to other reasons at the discretion of the investigators
Study sites (1)
WI
- American Family Children's Hospital PICU · Madison, WI 53792Talal Al Hendawi, MD · Sub-investigatorNeil Munjal, MD · Principal investigatorMore trials in Madison